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Not yet recruiting NCT07557862

Multi-Site STARgraft (10401) Trial

No phase Interventional End Stage Renal Disease (ESRD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: STARgraft (10401), Gore Propaten.
Who it may be relevant to
Registry conditions: End Stage Renal Disease (ESRD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Colombia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multi-Site Randomized Controlled Trial of STARgraft (10401) Vascular Graft for Hemodialysis Access

Overview

This is a multi-site, single-blind with parallel group, randomized controlled trial of Healionics STARgraft (10401) vascular graft for hemodialysis access compared with a market-leading commercially available ePTFE vascular graft (Gore Propaten Vascular Graft).

Interventions

  • Device STARgraft (10401)
    Device: STARgraft (10401) Surgical implantation of STARgraft (10401) for Hemodialysis in the upper forearm.
  • Device Gore Propaten
    Device: Gore Propaten Surgical implantation of Gore Propaten for Hemodialysis in the upper forearm.

Primary outcome measures

  • Safety: Subjects with Major Adverse Event [Time frame: 6 months]
  • Effectiveness: Primary Unassisted Patency [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • The patient requires the creation of vascular access for hemodialysis secondary to a diagnosis of End-Stage Renal Disease (ESRD) and intends to use the Vascular Graft device for arteriovenous (AV) access.
  • The patient is currently on hemodialysis or intended to begin hemodialysis within 60 days following placement of the device.
  • Adult patients, 18 years or older.
  • Patient has given informed consent to participate in the trial.
  • Stated willingness to comply with all trial procedures and availability for the duration of the trial.
  • Able to effectively communicate with trial personnel.
  • Life expectancy judged to be at least 2 years with consideration of patient frailty.
  • Axillary vein approximately 7 mm in diameter or greater.
  • Brachial artery approximately 4 mm in diameter or greater.
  • Acceptable cardiac risk level (Cardiac Output ≥ 3.5 L/min, Pulmonary Artery Pressure ≤ 50 mmHg, and Ejection Fraction ≥ 40%).
  • Systolic blood pressure equal to or greater than 120 mmHg.
  • Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram.

Exclusion criteria

  • Unable or unlikely to comply with trial protocol and/or follow-up.
  • Pregnancy.
  • Previous history of peritoneal dialysis (PD) treatment within the last 2 months
  • Central venous catheter located on same side as intended implant location.
  • Clinical morbid obesity (BMI > 40).
  • Anatomical limitations, including issues discovered intraoperatively during vessel exposure.
  • Immunodeficiency syndrome.
  • History of hypercoagulation or bleeding disorders.
  • Elevated platelet count > 1 million per microliter of blood.
  • History of heparin-induced thrombocytopenia syndrome (HIT).
  • Medically confirmed stenosis or compromised valves in the veins downstream of the implant site.
  • Inadequate arterial flow or pressure proximal to the implant site.
  • Currently participating in another investigational drug or device trial which may clinically interfere with any endpoints of this trial.
  • Fever greater than 38°C.
  • Known allergic reaction to silicone.
  • Confirmed or suspected bacterial, viral or parasitic infection within 8 weeks prior to graft implant, or ongoing symptoms.
  • Uncontrolled or poorly controlled diabetes.
  • History or evidence of severe cardiac disease.
  • Any other condition which, in the judgment of the Investigator, would preclude adequate evaluation or impact patient safety or trial conduct.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Colombia · 1 center
  • Clinica Farallones — Cali

Identifiers

NCT: NCT07557862 · 00635

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗